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NCT00125827 · ClinicalTrials.gov registry record · Phase 1
Study of Oral Clofarabine Administered Daily for 5 Days in Adult Patients With Refractory Solid Tumors
A Phase 1 study, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT00125827: Completed Phase 1 study, sponsored by Genzyme, a Sanofi Company.
NCT00125827 is a Phase 1 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00125827, a Phase 1 study, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. This is a research study of clofarabine that will be given to patients (orally) with advanced cancerous tumors or cancerous tumors that have spread in which standard drugs are no longer effective or no reliable effective treatment is available. The purpose of this study is to find the answers to the following research questions: 1. What is the largest dose of oral clofarabine that can be safely given daily for 5 days followed by 23 days of rest and repeated every 28 days? 2. What are the side effects of clofarabine when given on this schedule? 3. How much oral clofarabine is in the blood at specific times after administration and how does the body get rid of the drug? 4. Will oral clofarabine help treat solid tumor cancer?
Interventions
- DRUG clofarabine (oral formulation)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2003-10 |
| Est. Completion | 2006-02 |
| Phase | Phase 1 |
What the finished NCT00125827 record still lists
NCT00125827 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 1 intervention - of which clofarabine (oral formulation) is the first listed.
NCT00125827 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00125827 about?
NCT00125827 is a clinical study titled "Study of Oral Clofarabine Administered Daily for 5 Days in Adult Patients With Refractory Solid Tumors". Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. This is a research study of clofarabine that will be given to pa...
What is the current status of trial NCT00125827?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2003-10. Estimated completion is 2006-02.
What interventions are being tested in trial NCT00125827?
The interventions under investigation include: clofarabine (oral formulation) (DRUG).
Who is sponsoring clinical trial NCT00125827?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00125827's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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